Bayer announced that the FDA granted expanded approval for Stivarga (regorafenib) to include systemic treatment of patients with hepatocellular carcinoma (HCC) who were previously treated with Nexavar (sorafenib). The company noted that the decision makes the multi-kinase inhibitor the first new treatment for HCC approved in a decade. Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, also pointed out "this is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has stopped responding to initial treatment with [Nexavar]."
According to the FDA, the decision was supported by safety and efficacy data from the Phase III RESORCE trial of 573 patients with HCC who experienced tumour progression following treatment with Nexavar. Results from the study, unveiled last year, demonstrated that the therapy was associated with a significant median overall survival of 10.6 months, versus 7.8 months for patients given placebo.
Additionally, the median progression-free survival for patients in the Stivarga arm was 3.1 months, compared to 1.5 months for the placebo group, while the overall response rate was 11 percent and 4 percent, respectively, the agency noted.
The FDA had previously awarded both priority review and orphan drug designations to Stivarga for the second-line treatment of HCC. The treatment remains under review for this indication in Europe and Japan, with decisions expected later this year.
Stivarga was initially cleared by the FDA in 2012 for the treatment of certain patients with metastatic colorectal cancer, and its indication was later expanded to include patients with advanced gastrointestinal stromal tumours that are unresectable or no longer responsive to treatment. Bayer previously identified the drug as one of five therapies expected to help drive more than 10 billion euros ($10.9 billion) in annual combined revenue.
The wholesale price of Stivarga is $14 881 for one course of treatment, although Bayer said it offers several assistance programmes to provide free medication "to eligible Nexavar and Stivarga patients."
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